Clinical research — especially involving oncology trials — is evolving with the introduction of new therapies and therapeutic mechanisms. These raise new and sometimes challenging questions for IRBs reviewing the study protocols.

IRB questions sometimes arise about the role and responsibility of community members/nonscientists on review boards. Should their — and other nonaffiliated members’ — contributions be limited? Do they have enough training to be primary or secondary reviewers?

The National Institutes of Health recently delayed the effective date of its requirement to designate a single IRB in research involving multiple boards, but NIH officials have lost none of their enthusiasm for the idea.

Medical Marijuana Inc. announced it is working with an Israel-based contract research organization to begin a clinical proof of concept study with its cannabidiol and gabapentin chewing gum product to treat restless leg syndrome in patients.